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GUIDANCE DOCUMENT

E3 Structure and Content of Clinical Study Reports July 1996

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1995-D-0201
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The objective of this guideline is to facilitate the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions. The regulatory authority-specific additions will consist of modules to be considered as appendices, available upon request according to regional regulatory requirements.
 

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